Nihon Kohden Afib Detection Program QP-039P
FDA 510(k) K152305 · Nihon Kohden Corporation
510(k) numberK152305
Submission
- Device name
- Nihon Kohden Afib Detection Program QP-039P
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- August 14, 2015
- Decision date
- April 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
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| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
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Questions and answers
When was Nihon Kohden Afib Detection Program QP-039P cleared by the FDA?
Nihon Kohden Afib Detection Program QP-039P (K152305) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 238 days after the submission was received.
What is the product code of K152305?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.